Supersonic therapeutic device with means for introducing fluid into a body cavity



EXNHNE 1 .Hip

Dec. 19, 1967 E. E. sHELDoN 3,358,677

surnsomc THERAPEUTIC DEVICE wma MEANS FOR INTRODUCING FLUID INTO A BODY CAVITY Filed oct. 23, 1964 5?/ U/ ,f

INVENTOR. Du/APD [HJM/Z .Sl/H00 A TTMNEY United States Patent O s 353,677 sUPERsoNrC THERAPEUTIC DEVICE wrm MEANS Eon INTRODUCING FLUID INT A BODY cAvrrY Edward Emanuel Sheldon, 30 E. 40th St., New York, NX. 10016 Enea oct. z3, 1964, ser. No. 405,961 11 Claims. (ci. 12s-24) ABSTRACT oF THE DISCLOSURE This invention relates to novel devices for treatment of hollow organs such as uterus and comprises in combination means for producing a supersonic energy beam, means for injecting fluid into cavity of said organ and means for transmitting said supersonic energy to the walls of said cavity of said organ. In one embodiment of this invention, the supersonic beam comprises multiplicity of supersonic currents traveling in different directions simultaneously. In another embodiment of the invention, the supersonic energy producing means is mounted within the cavity of the organ and means is provided for directing the beam of supersonic energy.

This invention relates to the novel method and device for treatment of infections and of tumors benign and malignant of the uterus and of other inaccessible organs. The present treatment of the chronic infection of the cervix of the uterus or of the body of the uterus is very ineffective. This condition is chronic and does not respond well to any form of treatment. In view of the fact that chronic infection of the cervix is a strongly predisposing factor for the development of the cancer of the cervix which is one of the most frequent sites of cancer in women, there is an urgent need for the improvement of therapy in this eld.

My novel device, for treatment of remote organs such as uterus uses supersonic waves for the treatment of pathological conditions. It should be understood, however, that my device may be also used for the treatment of other remote organs. It was found that the supersonic waves of the frequency between 5000 kc. and 100,000 kc.

produce beneficial effects in the chronic 1n ection o e mucosa lining the inside surface of organs.

It was furthermore found that the efllciency of treatment by means of fluids containing medicines or ointments is greatly increased by' a simultaneous use of supersonic radiation. It is believed that this improvement in therapeutical effects of medicines, which are rather ineffective at present, resides in the ability of solution of said medicines to penetrate in the most inaccessible recesses of the mucosa membrane and reach thereby all foci of infection.

It should be also understood that my invention is not limited to any particular frequency of supersonic waves and that many modifications of the type of supersonic waves come within the scope of my invention.

The invention will be better understood when taken in combination with the accompanying drawings.

In the drawings FIGURE 1 represents the novel treatment device.

FIGURE 2 represents a modification of said device.

FIGURE 3 represents another modification of the treatment device.

FIGURE 4 represents a modification of the treatment device, which comprises a source of light for focusing on the pathological area.

FIGURE 1 represents the novel device 5 for treatment of the uterus and of the cervix. The device 5 comprises a source of supersonic energy 10, which may be in the form of a piezoelectric transducer such as quartz or ceramic. It may be also in the form of a magnetostrictive or ferroelectric transducer. It may be also in the form of an air whistle supersonic generator such as Hartmann generator, or it may be in the form of jet fluid supersonic generator, such as I E. Vibrating Reed supersonic generator manufactured by Sonic Engineering Company. In the simplest form, the supersonic source 10 may be made of Lagevins sandwich, or of a focused ceramic transducer. It should be understood that all types of supersonic generators may be used in my invention.

The supersonic generator 10 may be mounted in the tank 9 which is disposed outside of the patients body and contains a sterilized liquid such as water, saline, oil or fluid containing medicines. The novel uterine adaptor 3 has a wide portion 3a and a narrow portion 3b. The wide portion 3a extends from the tank 9 to the cervix of uterus 2. The narrow part 3b extends from the external orifice of the cervix into the cervical canal 2a or beyond into uterine cavity. The adaptor 3 may be made of a plastic or of a metal. The plastic such as Teflon was found to be very suitable for the purposes of this invention. The narrow part 3b of the adaptor 3 is introduced into the cervical canal 2a and is anchored there by means of an inflatable ring 15 or by means of a suction cup 16, to be described later. The adaptor 3 is connected by means of tubing 13 to the source of fluid 6 such as sterilized `ygztenr, Eline, or m The source of fluid 6 is connected to the pumping unit 7. The stop-valve 12 controls the flow of fluid into adaptor 3. After the adaptor 3 is inserted into the cervical canal, the valve 12 is opened and the fluid is directed into the uterine cavity 1a. The uterine cavity has a variable size but usually it has the size of the order of a few cubic inches only. The uterine cavity 1a has to be filled with fluid but over-distension should be avoided to prevent escape of the fluidV into Fallopian tubes. The manometer 8 connected to the adaptor 3 serves to regulate the amount of fluid. It was found that the pressure of fluid should not exceed 200 mm. Hg. After the uterine cavity has been tlled with liquid, the adaptor 3 is coupled to the sonic generator 10 by immersing its outside end in the tank 9. The tank 9 is provided with walls 11 made of material which is reflecting for supersonic waves such as cork or rubber mixed with tungsten chips. The reflecting walls 11 cause production of standing supersonic waves. This arrangement is important for the efficiency of the therapy as the multiplicity of reflected supersonic waves insures that each recess of the uterine cavity will be reached by some supersonic Y waves. The supersonic waves generated in tank 9 are transmitted into the fluid contained in the adaptor 3 and can reach therefore the uterine cavity 1a without attenuation.

In some cases the tank 9 may be omitted and the adaptor may be coupled directly or by means of an intervening oil lm to the transducer 10. It was found that in such case the walls of adaptor 3 should be coated with material reflecting supersonic waves, as was explained above.

It should be understood that the supersonic generator may operate by pulse waves or in aggiinullsmanner. In addition, it was found that the intensity of supersonic waves s lLliLOl-XQM/fg It was found that suc treatments of a vfew minutes duration proved to be beneficiaLtgpatieptswwerin ro nigigrgammations 2 t cerv I igw'uidY the u terus. It should be understood, however, that my invention is not limited to the treatment of the uterus but it may be applied to other inaccessible organs as well.

In some cases the adaptor 3 must be provided with means for blocking the lumen of the cervical canal in order to prevent the escape of fluid from the uterine cavity. This was accomplished by making the walls of the narrow section 3b of the adaptor 3 much thinner than the rest of the adaptor so that they may distend under the pressure of the injected fluid and close thereby the cervical canal. In some cases it is preferable to make the walls of the thin part 3b of a different material than the rest of the adaptor, for example, of a distensible rubber or plastic. In other cases it is preferable to anchor the adaptor 3 in the cervical canal and to block off the cervical canal by using an inflatable member such as ring 15, which is connected to an outside source of air. This construction is shown in FIGURE 2. The inflatable ring 15 surrounds the adaptor part 3b. When it is inflated it will close the space between said adaptor 3b and walls of the uterine canal 2a.

In other cases it is preferable to use instead of a ring 15, or in addition to it, a suction cap 16 which is mounted on the adaptor 3 and which will adhere to the outside orifice of the cervical canal 2a blocking thereby the escape of fiuids from the uterine cavity.

Another modification of my invention is shown in FIG- URE 3. In this embodiment of invention the supersonic generator 11a surrounds the part of the adaptor 3 which is outside of patients body. The supersonic generator 11a may be of one of piezoelectric ceramics or of ferrites and may have a cylindrical or semi-cylindrical shape which will cause focusing of the supersonic waves into fiuid contained in the adaptor 3. This arrangement is useful in cases in which the fluid in the uterine cavity is forced to circulate continuously through the adaptor 3. Any pathogenic organisms fiushed out of recesses of mucosa membrane will be brought into the region of focused supersonic radiation and will be destroyed by said strong supersonic radiation. This arrangement permits the use of powerful supersonic radiation without endangering patients tissues, which was not possible in the previously described embodiments of invention. In some cases the introduction of the adaptor 3 or 20 into the uterine cavity may be difiicult. In such cases the adaptor 3 or 20 will be positioned in the adjacent organ such as vagina. The supersonic waves will propagate from vagina into uterus. This method is not as efficient as the ones described above but it may be in some cases the only proper way to treat the patient.

Another modification is shown in FIGURE 4. In this embodiment 25 of invention the supersonic generator 21 is placed within the uterine cavity or within any other organ to be treated. The adaptor 20, which is similar to the adaptor 3 described above, is introduced into the uterine cavity 1a. The adaptor 20 is connected to the source of fiuid 6 which is again connected as a pumping member 7 as was described above. The adaptor 20 is provided with a small supersonic generator 21 mounted on its distal end, which is within the organ to be treated. The supersonic generator 21 may be of any type as wasaxplained above. The supersonic generator 21 may have a planoconcave shape to focus the emittted beam of supersonic energy. The generator 21 is connected to the outside source of electrical potential as it is well known in the art. In some cases a small plano-concave lens 23 such as of a metal or a plastic such as polystyrene may be attached to the generator 21 for better focusing of the supersonic beam. The size anvdapggofthgupersoniclen 23 will depend on r'ea on which the supersopi beam rom" "iesionca be determined beefhegtreatplentl'bygpsing one of my endoscopic devices, i t j suppgssile to select a proper lens for each patient before the treatment.' This adaptor 20. `Each bundle 26 of fibers is provided with a miniature lens 27 to focus the light emitted by said bundle onto the wall of the uterus. The fibers 26a receive their light from the source of light 28 which is mounted outside of the patients body. In the operation of my device the fine beam of focused light projected by one of the lenses 27 is directed to the center of the lesion underendoscopic control. The beam of supersonic energy has to cover said lesion. In this way the treatment device 2S, once it is focused by means of the light beam from the lens 27 onto the diseased area, automatically delivers the beam of supersonic radiation to said pathological area. As the supersonic radiation beam is essentially confined to the lesion itself, it may be made very strong without endangering the rest of the treated organ.

The adaptor 20 is provided with openings 30 for introduction of fiuid into uterine cavity 1a.

In some cases the focusing light may be mounted on the supersonic generator 21 instead of on the sidewalls of the adaptor 20, as was explained above. In other cases the focusing light may be mounted in the center of the adaptor 20 -below the supersonic generator 21. In such case the supersonic generator 21 must be of a light transparent material such as quartz. In this preferred modification of my light focusing system, the bundle of illuminating fibers 26 and its focusing lens 27 are mounted in the center of the adaptor 20.

A further refinement of the treatment device 2-5 is to mount the supersonic generator 21 on the universal joint. The motion of universal joint may be controlled from the outside of the patients body.

The treatment device 2S may be further improved by replacing one bundle 26 of illuminating fibers 26a with an endoscopic bundle of fibers which permits visual observation of the treated organ. The endoscopic bundle may be fiexible or rigid and is constructed of light conducting fibers 26a which are coherently fixed at `their ends. This means that the end-faces of all fibers are arranged in the same spatial relationship to e-ach other at each end of the bundle 26. The endoscope bundle is provided with a focusing lens at its distal end and with a magnifying ocular at its proximal end. The focusing lens may be controlled from the outside of the patient. In some cases fthe endoscopic bundle may also carry its own illuminatng means. The use of the endoscopic bundle permits visual ob servation of the focusing light from bundle 26 on the area to be treated.

It should be understood that the devices described above may be used for the treatment of other organs than the uterus, such as accessory nasal sinuses, biliary ducts, pancreatic ducts, urinary tract etc. In particular the above described devices were found to be effective in breaking up stones in biliary passages, in urinary passages, in the pancreatic ducts and in salivary ducts. They will permit therefore to reduce the scope of surgery necessary for extraction of such stones.

It should be also understood that in case which the introduction of the adaptor 3 or 20 into the organ to be treated is difiicult, the adaptors 3 or 20 maybe then placed in an adjacent organ. The supersonic waves from the generator will be then sent into diseased organ from said adjacent organ. This method of treatment is not as efficient as one described above but it may be in some cases the only practical way to treat the patient.

It should be understood that all modifications of my invention described above may be used for treatment of various organs 'of humans and of animals as well. It should -be also understood that the term supersonic waves embraces all forms of sonic energy regardless of their frequency.

Although there has been described a preferred embodiment of this novel invention, many variations and modications will now be apparent to those skilled in the art. Therefore, this invention is to be limited, not by the specie disclosure herein, but only by the appending claims.

I claim:

1. A device for treatment of a remote organ comprising in combination a source of Supersonic energy, a narrow hollow member adapted in size and shape for introducing into said organ, means for injecting fluid through said hollow member into said organ, means for coupling said hollow member with said source of supersonic energy, and means for applying said supersonic energy from said source to said organ through said hollow member, said device comprising furthermore a distensible member attached to said hollow member, and surrounding said hollow member.

2. A device for treatment of a remote organ comprising in combination a source of supersonic energy, a narrow hollow member adapted in size and shape for introducing into said organ, means for injecting uid through said hollow member into said organ, means for coupling said hollow member with said source of supersonic energy, and means for applying supersonic energy from said source to said organ through said hollow member, said device comprising furthermore means for producing a focused beam of light for projecting said beam of light on said organ.

3. A device for treatment of a remote organ comprising in combination a source of supersonic energy, a narrow hollow member adapted in size and shape for introducing into said organ, means for injecting uid through said hollow member into said organ, said source of supersonic energy being mounted on the end of said hollow member introduced into said organ, and means for applying said supersonic energy from said source to said organ.

4. A device for treatment of a remote organ comprising in combination a source of supersonic energy, a narrow hollow member adapted in size and shape for introducing into said organ, means for injecting uid through said hollow member into said organ, said hollow member comprising furthermore means for producing a focused beam of light for projecting said light onto said organ, in said device said source of supersonic energy being mounted on the end of said hollow member introduced into said organ and being transparent to said focused beam of light, and means for applying said supersonic energy from said source to said organ.

5. A device for treatment of an internal hollow organ of the body, said organ having a constricted narrow orifice part and being the uterus, comprising in combination means for producing a defocussed beam of supersonic energy, said beam comprising multiplicity of supersonic currents traveling in multiple and different directions simultaneously, said means producing supersonic energy being so constructed and arranged so as to be mounted outside of said body, a'hollow member adapted in size and shape for introducing into the cavity of uterus, said member having the length greater than its diameter, a source of uid with means for injecting said uid through said hollow member into said cavity and filling said cavity with said uid, means for coupling said fluid with said means producing supersonic energy, and means for transmitting said defocussed beam of supersonic energy to walls of said cavity of said organ through said ud whereby all recesses of said cavity are subjected to the action of said uid.

6. A device as defined in claim 5 which includes means for reflecting said supersonic energy of said hollow member comprise means reflecting said sonic energy.

7. A device as defined in claim 5 which includes means for preventing at least partially the escape of said fluid t from said cavity.

8. A device as defined in claim 5 includes means for injecting under pressure to provide distension of said cavity of uterus.

9. A device as defined in claim 5 which includes means for providing to said uicl a pressure not exceeding 200 mm. of Hg.

10. A device as defined in claim S in which said uid contains treatment ingredients.

11. A device as defined in claim 7 in which said fluid contains treatment ingredients.

References Cited UNITED STATES PATENTS 2,230,997 2/ 1941 Chambers et al. 12S-24.05 2,407,690 9/ 1946 Southworth 12S-24.05 2,852,019 9/1958 Fry 12S-24.05 3,237,623 3/ 1966 Gordon 128--24.05

OTHER REFERENCES Mundt et al.: American Journal of Opthalmology, p. 491, March 1956, Copy in Group 335.

LAWRENCE W. TRAPP, Primary Examiner. 

5. A DEVICE FOR TREATMENT OF AN INTERNAL HOLLOW ORGAN OF THE BODY, SAID ORGAN HAVING A CONSTRICTED NARROW ORIFICE PART AND BEING THE UTERUS, COMPRISING IN COMBINATION MEANS FOR PRODUCING A DEFOCUSSED BEAM OF SUPERSONIC ENERGY, SAID BEAM COMPRISING MULTIPLICITY OF SUPERSONIC CURRENTS TRAVELING IN MULTIPLE AND DIFFERENT DIRECTIONS SIMULTANEOUSLY, SAID MEANS PRODUCING SUPERSONIC ENERGY BEING SO CONSTRUCTED AND ARRANGED SO AS TO BE MOUNTED OUTSIDE OF SAID BODY, A HOLLOW MEMBER ADAPTED IN SIZE AND SHAPE FOR INTRODUCING INTO THE CAVITY OF UTERUS, SAID MEMBER HAVING THE LENGTH GREATER THAN ITS DIAMETER, A SOURCE OF FLUID WITH MEANS FOR INJECTING SAID FLUID THROUGH SAID HOLLOW MEMBER INTO SAID CAVITY AND FILLING SAID CAVITY WITH SAID FLUID, MEANS FOR COUPLING SAID FLUID WITH SAID MEANS PRODUCING SUPERSONIC ENERGY, AND MEANS FOR TRANSMITTING SAID DEFOCUSSED BEAM OF SUPERSONIC ENERGY TO WALLS OF SAID CAVITY OF SAID ORGAN THROUGH SAID FLUID WHEREBY ALL RECESSES OF SAID CAVITY ARE SUBJECTED TO THE ACTION OF SAID FLUID. 